Amgen

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Amgen is only weeks away from an anticipated FDA approval for its PCSK9 cholesterol lowerer. Already approved in Europe, the drug is expected to quickly reap blockbuster sales. The biotech's current portfolio of products, along with cost cuts, have helped set the stage for a big year that could possibly include M&A.

Amgen, long criticized over its appetite for moonshot R&D projects, scaled back its research budget by more than 10% in the second quarter, part of a companywide effort to cut costs while advancing a make-or-break pipeline.

Amgen shocked the industry in May when it cut ties with an AstraZeneca-partnered psoriasis treatment after spotting alarming rates of suicidal thoughts among patients taking the antibody. But its former collaborator is remaining optimistic about the once-promising treatment, tentatively moving toward an FDA filing.

Novartis' Sandoz may have the first FDA-approved biosimilar in Zarxio, but it doesn't have permission to launch--and it won't be getting that until September, the country's top patent court ruled Tuesday.

Amgen's new cholesterol fighter may be second in line for FDA approval in the U.S. But in Europe, it's officially first. Amgen's PCSK9 contender Repatha slipped past Sanofi and Regeneron's Praluent to win E.U. approval Tuesday, with a broad label that could help it build sales quickly.

A cadre of drugmakers is pressing toward late-stage trials with new injectable treatments in the long-stagnant field of migraine therapy, racing to capitalize on what analysts say is a multibillion-dollar market.

Amgen may be running a beat or two behind Regeneron and Sanofi in search of the first FDA approval for a PCSK9 drug, but the Big Biotech scooped up the very first approval in Europe today for Repatha (evolocumab), giving the company boasting rights as first mover in what is widely seen as a new blockbuster market in the making.

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